a study of bl-b01d1+pd-1 monoclonal antibody in patients with extensive-stage small cell lung cancer

Conditions: Extensive-stage Small-cell Lung Cancer

Summary: this study is a phase ii clinical study to explore the efficacy and safety of bl-b01d1 + pd-1 monoclonal antibody combination therapy in patients with extensive-stage small cell lung cancer.


Eligibility criteria:
inclusion criteria: 1. subject volunteered to participate in the study and signed an informed consent; 2. male or female aged ≥18 years and ≤75 years; 3. expected survival time ≥3 months; 4. ecog score 0-1; 5. newly diagnosed patients with extensive-stage small cell lung cancer confirmed by histopathology and / or cytology; 6. a archived tumor tissue sample or fresh tissue sample of the primary or metastatic lesion must be provided within 3 years; 7. at least one measurable lesion meeting the recist v1.1 definition was required; 8. no blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements; 9. the toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by nci-ctcae v5.0; 10. for premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; all enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. exclusion criteria: 1. prior use of adc drug therapy with small molecule toxins as topoisomerase i inhibitors; 2. prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer; 3. pathology suggested small cell carcinoma containing non-small cell carcinoma components; 4. subjects had used immunomodulatory drugs within 14 days before the first use of the study drug ; 5. screening the history of severe cardiovascular and cerebrovascular diseases in the first half of the year ; 6. qt interval prolongation, complete left bundle branch block, iii degree atrioventricular block, frequent and uncontrollable arrhythmia ; 7. active autoimmune diseases and inflammatory diseases ; 8. receiving long-term systemic corticosteroid therapy or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy prior to the first dose; 9. other malignancies that have progressed or require treatment within 5 years prior to the first dose; 10. have ild requiring steroid therapy, or currently have ild, or suspected ild at screening; 11. prior to initiation of study treatment, there were: a) poorly controlled diabetes mellitus; b) with severe complications of diabetes; c) glycosylated hemoglobin levels of 8% or more; d) hypertension that is poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy; 12. unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; except for infusion set-related thrombosis; 13. concurrent pulmonary disease leading to severe clinical impairment of respiratory function; 14. patients with active central nervous system metastases; 15. patients with large serosal effusions, or symptomatic serosal effusions, or poorly controlled serosal effusions; 16. history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipient component of the experimental drug; 17. prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 18. positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis b virus infection, or active hepatitis c virus infection; 19. severe infection within 4 weeks prior to first dose of study drug; lung infection or active lung inflammation within 4 weeks; 20. have participated in another clinical trial within 4 weeks prior to the first dose; 21. have a history of psychotropic substance abuse and cannot be abstained from or have a history of severe neurological or psychiatric disorders; 22. imaging examination showed that the tumor had invaded or encapsulated the large blood vessels in the chest; 23. severe and non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed policy; 24. clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing the informed policy; 25. subjects who are scheduled to receive or receive a live vaccine within 28 days prior to the first dose; 26. other conditions that the investigator considers unsuitable to participate in this clinical trial.